Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1— 510(k) K162843
Substantially EquivalentTerumo Cardiovascular Systems Corporation
FDA 510(k) clearance K162843 for Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1, Substantially Equivalent on 2016-11-17. Applicant: Terumo Cardiovascular Systems Corporation.
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corporation
- Product code
- Code DWB
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ann Arbor, MI, US
Adverse events under product code DWB
product code DWB- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.